Dietary Behavior Intervention in African-Americans at Risk for Cardiovascular Disease

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Abstract

In 2020, a protocol paper manuscript was published in BMC Pilot and Feasibility Studies. During 2020-2021, Phase 1 of the Dietary Behavior in African-American Adults at Risk for Cardiovascular Disease Study was completed. The study procedures completed under this Phase include recruitment of 20 African-American adults living in either Ward 7 or Ward 8 of Washington, D.C. who have one self-reported risk factor for cardiovascular disease. The study participants were recruited through sampling of a larger NHLBI community-based study. A total of five focus groups were conducted between March and April of 2021. Participants also completed electronic surveys. The focus groups were moderated or co-moderated by the study PI, lead AI or a selected AI. Qualitative data from the groups and survey data were analyzed starting in June 2021. Data from this Phase was presented in September 2021 at the NIH Food Security and Nutrition Conference. Qualitative analysis of the data was started in September of 2021 and commenced in April 2022. Manuscript preparation from the focus group data is in process. A methodology-based manuscript was submitted in April 2022 based on the virtual adaptation of the protocol. After evaluation of the data, the protocol states that the research team will meet to evaluate adaptations or changes to Phase 2 of the study. In 2023, the research team met to evaluate the adaptations and acceptability of the study. Modifications to Phase 2 of the study were done accordingly. Recruitment for Phase 2 started in April 2024 and was completed in June 2024. A total of 26 participants were recruited, of which 5 were male. Intervention sessions started June 2024 to August 2024. Baseline visits took place prior to the start of the intervention in Mary 2024. Follow up visits occurred in August and November of 2024. As a community-engaged study, participant feedback was solicited throughout the intervention sessions. Due to changes in behavior, participants asked for additional classes to continue their behavior changes. A modification to the protocol was submitted and approved in the Fall of 2024 for an additional 8 classes and two follow up visits. The classes were to resume in February 2025, but did not start until April 2025. The follow up visits occurred in June and August of 2025. Resources used for the completion of this Phase included electronic consent processes, clinical rooms within the NIH Clinical Center, utilization of BTRIS and NIDDK REDCap services for survey data management and contract transcription service for qualitative data collection.